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  5. A C Calderoni & Co. Inc. - 547725 - 03/14/2018
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A C Calderoni & Co. Inc. MARCS-CMS 547725 —

Recipient Name
Mr. Robert J. Baciocco
A C Calderoni & Co. Inc.

99 N. Hill Drive
Brisbane, CA 94005
United States

Issuing Office:
San Francisco District Office

United States



Black HHS-Blue FDA Logo



1431 Harbor Bay Parkway
Alameda, CA 94502-7070 


March 14, 2018                           
Mr. Robert J. Baciocco, CEO
A.C. Calderoni & Co.
99 N. Hill Drive
Brisbane, CA 94005
Dear Mr. Robert J. Baciocco, CEO:
The U.S. Food and Drug Administration (FDA) inspected your juice and drink mixer manufacturing facility, located at 99 N. Hill Drive, Brisbane, CA 94005, on December 14, 18, and 20 2017. During this inspection, we found that you have serious violations from the FDA's juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). This inspection resulted in FDA’s issuance of a Form FDA-483 Inspectional Observations (FDA-483), at the conclusion of the inspection. 
In accordance with 21 CFR Part 120.9, failure of a processor to implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of the Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [U.S.C. § 342(a)(4)]. Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov1.
The violations include, but are not limited to, the following:
1.       Your firm failed to have a written hazard analysis developed to determine whether there are food hazards that are reasonably likely to occur for each type of juice processed and to identify control measures that control those hazards as required by 120.7(a). Specifically, your firm informed our investigator that no hazard analysis was done to identify the food hazards reasonably likely to occur in your Royal brand 100% lemon juice from concentrate, which your firm manufactures, packages and distributes. As a juice manufacturer, you are required to have done or conduct a hazard analysis to identify all hazards associated with your juice products manufacturer at your facility. Part of that process includes identifying “pertinent organisms”, which is the most resistant microorganism of public health significance that is likely to occur in the juice. You have not identified Listeria monocytogenes and metal fragments as potential hazards. Once identified you are required to conduct a 5-log reduction process and perform final packaging of your juice within a single production facility operating under current good manufacturing practices. You stated there is no 5-log reduction done to your Royal brand 100% lemon juice from concentrate as required by 21 CFR 120.24(c).  
2.       You do not have written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur, as required by 21 CFR 120.8(a). Specifically, you informed the investigator that your firm does not have a HACCP plan for the 100% Lemon Juice product produced by your firm.  You are required to establish and implement a HACCP plan that controls the potential Listeria monocytogenes and metal fragment hazards.  
3.      You did not monitor the conditions and practices during processing with sufficient frequency to ensure at a minimum, conformance with those conditions and practices specified in part 110 and in subpart B of part 117 of this chapter for current good manufacturing practices that include condition and cleanliness of food contact surfaces, prevention of cross-contamination form insanitary objects, maintenance of hand-washing, hand-sanitizing and toilet facilities, protection of food, food packaging material and food contact surfaces from adulteration, proper labeling, storage and use of toxic chemicals and control of employee health conditions in accordance with 21 CFR 120.6(b). Specifically, during the inspection you informed the investigator that you do not maintain sanitation records for documenting the monitoring of all eight key areas of sanitation.   You only maintain records for water safety testing obtained annually from the City of Brisbane and monthly pest control records from your contracted pest control firm. Additionally, your juice equipment is cleaned and sanitized once a month, and only flushed with hot water daily before production.  Daily equipment cleaning and sanitizing is essential to prevent contamination by microorganisms that pose a significant health hazard.  The eight key areas of sanitation must be implemented and monitored to protect product from contamination. It is your responsibility to ensure that your sanitation procedures include all eight areas and are completed, monitored and recorded in accordance with the regulation.
We may take further action if you do not promptly correct these violations. We may initiate a regulatory action without further formal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. You may wish to include in your response documentation of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and the Current Good Manufacturing Practice regulation (21 CFR Part 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act [21 U.S.C § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related cost.
Please send your reply to the Food and Drug Administration, Attention:
Sergio Chavez,
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case number 547725
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737. 
Sincerely Yours,
Darla R. Bracy, District Director
Office of Human and Animal Food
Division 5 West
Mr. Scott D. Hawley, Vice President
A.C. Calderoni & Co.
99 N. Hill Drive
Brisbane, CA 94005
David Mazerra, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435
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